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EC number: 231-141-8 | CAS number: 7440-31-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 July 2008 to 15 August 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Study conducted according to standard guideline
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tin
- EC Number:
- 231-141-8
- EC Name:
- Tin
- Cas Number:
- 7440-31-5
- Molecular formula:
- Sn
- IUPAC Name:
- tin
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material : Tin metal powder (2 – 11 µm)
- Physical state: Solid, grey powder
- Analytical purity: 99.99 %
- Impurities (identity and concentrations): Pb 0.0035 %, Sb 0.0010 %, Cu 0.0003 %, Au 0.0001 %, Al < 0.0001 %, Cd < 0.0001 %, Zn < 0.0002 %, Ag 0.0005 %, Bi 0.0018 %, As 0.0014 %, Fe < 0.0001 %, In 0.0002 %, Ni 0.0002 %, P 0.0016 % and S 0.0028 %
- Purity test date: 05/07/2008
- Lot/batch No.: 061184
- Expiration date of the lot/batch: August 2008
- Storage condition of test material: When not in use the test article was stored in a sealed container, at room temperature in the dark.
Constituent 1
- Specific details on test material used for the study:
- Particle size data is included in the attached image.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: Approximately 12 to 15 weeks old
- Weight at study initiation: 2.63 to 2.87 kg
- Housing: On arrival, rabbits were accommodated in cages that conform with the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989).
- Diet: Global Diet TRB 2930C (Harlan Teklad, Bicester, UK) available ad libitum. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer. (Global Diet 2030 was specified by the protocol, however the use of Global Diet TRB 2930C was not considered to affect the outcome or integrity of the study).
- Water: Mains water provided ad libitum provided via cage mounted water bottles. The water had been periodically analysed for specific contaminants.
- Acclimation period: 7 to 21 days
ENVIRONMENTAL CONDITIONS
- Temperature: 15 to 21 °C
- Humidity: 40 to 70 % (On three occasions the relative humidity exceeded the specified range with the highest value recorded being 74 %, this is not considered to have affected the integrity or outcome of the study).
- Air changes: 15 changes per hour
- Photoperiod: The rooms were illuminated by fluorescent strip lights for twelve hours daily.
IN-LIFE DATES: From 28 July 2008 to 15 August 2008
In order to enrich both the environment and the welfare of the animals they were, where practicable, provided with wooden Aspen chew blocks and hay.
The condition of the animals was assessed daily throughout the acclimatisation period of 7 to 21 days. A clinical inspection was performed prior to study commencement to ensure the animals were suitable for the test procedures. Overtly healthy animals were arbitrarily allocated to the study on the day before dosing. Both eyes of each rabbit were examined for indications of corneal, iridial or conjunctival damage or irritation. After initial visual examination, one drop of 1 % aqueous fluorescein solution was instilled into both lower conjunctival sacs, allowed to disperse for thirty seconds and removed from the eyes by irrigation with approximately 10 mL water for irrigation jetted gently from a syringe. The corneal surface was illuminated with an ultraviolet source and inspected for areas of absorption of the fluorescing dye that would indicate epithelial damage. Only rabbits with eyes free from damage or irritation were accepted onto study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
One dose consisting of 100 mg of test article was instilled into the left conjunctival sac of a single New Zealand White rabbit (the sentinel). The lower eyelid was gently prised away from the eyeball to create a receptacle for the dose. After instillation, the eyelids were held closed for a few seconds to prevent loss of the dose. The right eye remained untreated and served as a control to the treated eye. - Duration of treatment / exposure:
- Exposure was indefinite since no immediate rinsing occurred.
- Observation period (in vivo):
- Animals were assessed for the initial sting/pain response immediately after instillation of the test material. Ocualr assessments were performed at 1, 4 and approximately 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- One animal initially, followed by a further two animals.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Exposure was indefinite since no immediate rinsing occurred. The treated eyes were subject to fluorescein application and subsequent flushing with water at 24 hours post-instillation and this can be taken to have flushed away any residual test material.
SCORING SYSTEM: At examinations carried out 24 hours after treatemtn (and at the discretion of the observer, at any subsequent examination) the cornea was subject to application of 1 % aqueous fluorescein solution followed by irrigation with water and illumination by an ultraviolet sourve. Damage to the corneal epitheliam was revealed by absorption of the fluorescing dye into the epithelium or stroma. The scoring systems for initial pain response and ocular changes are reported below under section "Any other information on material and methods incl. tables)
TOOL USED TO ASSESS SCORE: pencil-beam torch
The pH of a 50 % dilution of tin metal powder in water was checked prior to exposure of the first eye. The test material was suspended in water at a 50 % w/v dispersion. The pH of the test material was determined to be 5 which is within the acceptable range.
Results and discussion
In vivo
Results
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Slight conjunctival redness apparent in one treated eye at 24 and 48 hours had resolved by the day 4 assessment
- Irritant / corrosive response data:
- Instillation of the test article caused no initial sting response.
Minimal conjunctival irritation was noted in two treated eyes 30 minutes and one hour after instillation.
No iridial effects were seen.
No corneal opacity was noted in two treated eyes. There was no corneal absorption of fluorescein solution when applied to these eyes at the 24-hour observation.
Easily discernible areas of corneal opacity were noted in one treated eye on Day 2, with scattered or diffuse areas of opacity noted on Day 3. The application of fluorescein solution at these time points gave fluorescence over an area of < 25 % of the corneal surface.
The eyes of all rabbits were overtly normal by the 72-hour examination. - Other effects:
- No observations indicative of systemic toxicity or ill health were noted for any rabbits during the course of the study.
Any other information on results incl. tables
Table 1: Individual and mean scores for cornea, iris and conjunctivae for classification according to Commission Directive 2001/59/EC
Rabbit Number and Sex |
Observation Time |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
32 M |
24 Hours |
0 |
0 |
0 |
0 |
48 Hours |
0 |
0 |
0 |
0 |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Total |
0 |
0 |
0 |
0 |
|
Mean Score |
0.0 |
0.0 |
0.0 |
0.0 |
|
33 M |
24 Hours |
0 |
0 |
0 |
0 |
48 Hours |
0 |
0 |
0 |
0 |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Total |
0 |
0 |
0 |
0 |
|
Mean Score |
0.0 |
0.0 |
0.0 |
0.0 |
|
34 M |
24 Hours |
2 |
0 |
0 |
0 |
48 Hours |
1 |
0 |
0 |
0 |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Total |
3 |
0 |
0 |
0 |
|
Mean Score |
1.0 |
0.0 |
0.0 |
0.0 |
Table 2: Individual ocular responses
Rabbit number and sex |
Initial sting response |
Observation |
Score at time after instillation |
||||||
½ hr |
1 hr |
4 hrs |
24 hrs |
48 hrs |
72 hrs |
||||
32M |
0 |
Cornea |
Opacity |
0# |
0# |
0# |
0* |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|||
33M |
|
Cornea |
Opacity |
0# |
0# |
0 |
0* |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
1 |
1 |
0 |
0 |
0 |
0 |
||
Chemosis |
1 |
1 |
0 |
0 |
0 |
0 |
|||
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|||
34M |
0 |
Cornea |
Opacity |
0# |
0# |
0 |
2* |
1* |
0 |
Area |
0 |
0 |
0 |
1 |
1 |
0 |
|||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
1 |
1 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|||
* Fluorescein applied to cornea # Small amount of test article visible on both eyelids |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Tin metal powder instilled as 100 mg into three rabbit eyes did not elicit any significant irritant reactions. Ocular changes (slight conjunctival and corneal responses) had resolved by day 4. No classification as an ocular irritant is appropriate.
- Executive summary:
Tin metal powder (2 -11 µm) was instilled, as 100 mg, into the lower conjunctival sac of three NZW rabbits. Ocular changes were assessed at 1, 4, 24, 48 and 72 hours post-exposure and fluorescein was applied after 24 hours.
Transient conjunctival redness and swelling occurred in two rabbits on day 1 and corneal opacity was briefly apparent for one animal on day 2/3. No iridial changes were noted. All reactions had overtly resolved by day 4 and the mean scores for each irritation parameter were below the threshold for classification.
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